Quality Systems

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Articles

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

The Basics of Aseptic Processing

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

FDA Removes Clinical Hold on Phase I/II Study of Angelman Syndrome Treatment

Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.

Verrica's Molluscum Treatment Rejected by FDA Following CMO Facility Deficiencies

US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.

Federal Court Enters Consent Decree Against Florida Compounder

Garrett Perry is a technical services specialist at Teknova, www.teknova.com.

As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases. 

How Pure is Pure? Understanding Reagent Purity Grades

Zillery A. Fortner is product marketing manager, Sparta Systems, A Honeywell Company.

The functionality of a digital quality management system (QMS) provides visibility into critical supplier activity and helps ensure a high-quality product. 

Mitigating Third-Party Risks: The Benefits of Extending Quality to the Supply Chain   

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, discusses how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

The Impact of Insufficient Oversight

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Microbial experts should employ proactive practices on the manufacturing floor, rather than relying on testing.

Moving Out of the Lab to Optimize Microbial Control

Aaron M. Robitaille is senior product marketing manager with Thermo Fisher Scientific.

Brandon J. Bills is product manager, Thermo Fisher Scientific.

Intelligent analytical tools detect impurities to help ensure the quality of small-molecule drug ingredients.

Quality Assurance/Quality Control